Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
8.1 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
25
Dose descriptor starting point:
NOAEC
Value:
813 mg/m³
Modified dose descriptor starting point:
NOAEC
Value:
203 mg/m³
Explanation for the modification of the dose descriptor starting point:

The infrequent exposure DNEL for systemic effects via the inhalation route is determined on the basis of the 90-day inhalation NOAEC for (3-chloropropyl)trimethoxysilane (813 mg/m3). The following correction was made: Correction for experimental exposure duration (6 h/d to 24 h/d): 6/24 (ECHA default). Therefore, the corrected NOAEC is: 813*(6 h/ 24 h) = 203 mg/m3.

AF for dose response relationship:
1
Justification:
Default
AF for differences in duration of exposure:
1
Justification:
Assessment factor for duration of exposure does not apply for infrequent exposure.
AF for interspecies differences (allometric scaling):
1
Justification:
Default (rat inhaled to human inhaled)
AF for other interspecies differences:
2.5
Justification:
Default
AF for intraspecies differences:
10
Justification:
Default (general population)
AF for the quality of the whole database:
1
Justification:
Default
AF for remaining uncertainties:
1
Justification:
Default
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
9.35 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Dose descriptor starting point:
NOAEC
Value:
813 mg/m³
Modified dose descriptor starting point:
NOAEL
Value:
935 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The infrequent exposure DNEL for systemic effects via the dermal route is determined on the basis of the 90-day inhalation NOAEC for (3-chloropropyl)trimethoxysilane (813 mg/m3). The following correction was made: Correction respiratory volume rat (24 hour) = 1.15 m³/kg bw. Therefore, the corrected NOAEL is: 813*1.15 = 935 mg/kg bw/day.

AF for dose response relationship:
1
Justification:
Default
AF for differences in duration of exposure:
1
Justification:
Assessment factor for duration of exposure does not apply for infrequent exposure.
AF for interspecies differences (allometric scaling):
4
Justification:
Default (inhaled rat to dermal human)
AF for other interspecies differences:
2.5
Justification:
Default
AF for intraspecies differences:
10
Justification:
Default (general population)
AF for the quality of the whole database:
1
Justification:
Default
AF for remaining uncertainties:
1
Justification:
Default
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.3 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
200
Dose descriptor starting point:
NOAEC
Value:
813 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
667.8 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The DNEL for systemic effects via the oral route is determined on the basis of route-to-route extrapolation from the inhalation NOAEC for (3-chloropropyl)trimethoxysilane (813 mg/m3) from the 90-day study in rats.

The following corrections were made to the NOAEC (inhaled): Correction respiratory volume rat (24 hour) = 1.15 m³/kg bw. Correction for dosing frequency: 5 days/7 days. Therefore, the corrected NOAEL is: 813*1.15*(5/7) = 667.8 mg/kg/day.

AF for dose response relationship:
1
Justification:
Default
AF for differences in duration of exposure:
2
Justification:
Default (sub-chronic to chronic)
AF for interspecies differences (allometric scaling):
4
Justification:
Default (inhaled rat to oral human)
AF for other interspecies differences:
2.5
Justification:
Default
AF for intraspecies differences:
10
Justification:
Default (general population)
AF for the quality of the whole database:
1
Justification:
Default
AF for remaining uncertainties:
1
Justification:
Default
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population